BEUDAMED
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    Blood Monitoring Unit (BMU 40), model no. 701040852 - Product Usage: is to monitor blood parameters during cardiopulmonary bypass (CPB) or similar procedures with extracorporeal circulation, which require continuous monitoring of the arterial and/or venous blood parameters: partial pressure of oxygen (pO2), temperature (TArt and TVen), oxygen saturation (SO2), hemoglobin (Hb) and hematocrit (Hct).

    FDA Recall
    Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code DRY·September 30, 2020

    Blood Monitoring Unit (BMU 40), model no. 701040852 - Product Usage: is to monitor blood parameters during cardiopulmonary bypass (CPB) or similar procedures with extracorporeal circulation, which require continuous monitoring of the arterial and/or venous blood parameters: partial pressure of oxygen (pO2), temperature (TArt and TVen), oxygen saturation (SO2), hemoglobin (Hb) and hematocrit (Hct).

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular Us Sales, Llc·November 18, 2020

    XLTEK EMU40EX EEG Headbox

    FDA Enforcement
    Class II ·Terminated·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·August 8, 2018

    XLTEK EMU40EX EEG Headbox

    FDA Recall
    Terminated ·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·Product code GWQ·May 15, 2018

    Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10995591, UDI Codes: (01)00630414599151(10)98034139(17)20210130 and (01)00630414599151(10)32478139(17)20210130 Atellica IM HER-2/neu (H2n) calibrator, 2 Pack, Catalog No. SMN 10995592, UDI Code (01)00630414599168(10)22695A49(17)20201211 ADVIA Centaur HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10308994, UDI codes : (01)00630414471235(10)43157138(17)20210130 (01)00630414471235(10)81653138(17)20210130 (01)00630414471235(10)99728138(17)20210130 (01)00630414471235(10)24043138(17)20210130 (01)00630414471235(10)32477138(17)20210130 Advia Centaur Systems HER-2/neu (H2n) calibrator, 2 Pack, Catalog No. SMN 10308993, UDI Codes: (01)00630414471228(10)64661A48(17)20201112 (01)00630414471228(10)81211A48(17)20201112 (01)00630414471228(10)91743A48(17)20201112 (01)00630414471228(10)22124A49(17)20201211 Product Usage: This product is intended to be used for in vitro diagnostic use in calibrating the ADVIA Centaur systems HER-2/neu assay.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc·October 28, 2020

    Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10995591, UDI Codes: (01)00630414599151(10)98034139(17)20210130 and (01)00630414599151(10)32478139(17)20210130 Atellica IM HER-2/neu (H2n) calibrator, 2 Pack, Catalog No. SMN 10995592, UDI Code (01)00630414599168(10)22695A49(17)20201211 ADVIA Centaur HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10308994, UDI codes : (01)00630414471235(10)43157138(17)20210130 (01)00630414471235(10)81653138(17)20210130 (01)00630414471235(10)99728138(17)20210130 (01)00630414471235(10)24043138(17)20210130 (01)00630414471235(10)32477138(17)20210130 Advia Centaur Systems HER-2/neu (H2n) calibrator, 2 Pack, Catalog No. SMN 10308993, UDI Codes: (01)00630414471228(10)64661A48(17)20201112 (01)00630414471228(10)81211A48(17)20201112 (01)00630414471228(10)91743A48(17)20201112 (01)00630414471228(10)22124A49(17)20201211 Product Usage: This product is intended to be used for in vitro diagnostic use in calibrating the ADVIA Centaur systems HER-2/neu assay.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code NCW·August 25, 2020

    Her2/Neu (c-erbB-2) (CB-1 1); 7.0 mL Catalog number 237M-18. In vitro diagnostic use - Analyte Specific Reagent Immunology - Analyte Specific Reagent

    FDA Enforcement
    Class II ·Terminated·Cell Marque Corporation·June 7, 2017

    Her2/Neu (EP3); 0.5 mL Catalog number 237R-25; 1.0 mL Catalog number 237R-26; 7.0 mL Catalog number 237R-28. Immunology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

    FDA Enforcement
    Class II ·Terminated·Cell Marque Corporation·June 7, 2017

    VENTANA PATHWAY anti-HER-2/neu (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (PATHWAY HER2 (4B5)); Model Number: 790-2991, Lot number: 680957, in vitro diagnostic.

    FDA Recall
    Terminated ·Ventana Medical Systems Inc·Product code MVC·September 17, 2009

    Her2/Neu (c-erbB-2) (CB-1 1); 7.0 mL Catalog number 237M-18. In vitro diagnostic use - Analyte Specific Reagent Immunology - Analyte Specific Reagent

    FDA Recall
    Terminated ·Cell Marque Corporation·Product code NYQ·May 5, 2017

    Her2/Neu (EP3); 0.5 mL Catalog number 237R-25; 1.0 mL Catalog number 237R-26; 7.0 mL Catalog number 237R-28. Immunology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

    FDA Recall
    Terminated ·Cell Marque Corporation·Product code NYQ·May 5, 2017

    Test kit used in the assessment of breast cancer patients for whom Herceptin therapy is being considered. BioGenex brand InSite HER-2/neu Monoclonal Antibody, Manual; Model number: AM134-5MP; Lot Numbers: AM134P1005

    FDA Recall
    Terminated ·Biogenex Laboratories·Product code MVC·February 9, 2006

    Test kit used in the assessment of breast cancer patients for whom Herceptin therapy is being considered. BioGenex brand InSite HER-2/neu Monoclonal Antibody, Automated; Model number: AM134-10MP; Lot Numbers: AM134P1005

    FDA Recall
    Terminated ·Biogenex Laboratories·Product code MVC·February 9, 2006

    Ventana Image Analysis System (VIAS) - PATHWAY anti-HER-2/neu (4B5) primary antibody with software version 2.3.0.2, Model Number: VIAS-799-10000-00, Pathology Image Analysis System, Ventana Medical Systems, Inc., Tucson, AZ 85755

    FDA Recall
    Terminated ·Ventana Medical Systems Inc·Product code NQN·June 26, 2007

    Test kit used in the assessment of breast cancer patients for whom Herceptin therapy is being considered. BioGenex brand InSite HER-2/neu IHC Kit, Manual; Model Numbers: RD134-60K; Lot Numbers: RD1340205, RD1340205X, RD1340205Y

    FDA Recall
    Terminated ·Biogenex Laboratories·Product code MVC·February 9, 2006

    Test kit used in the assessment of breast cancer patients for whom Herceptin therapy is being considered. BioGenex brand InSite HER-2/neu IHC Kit, Automated; Model Numbers: RD134-YAX; Lot Numbers: RD1340205, RD1340205X, RD1341105, RD1340206

    FDA Recall
    Terminated ·Biogenex Laboratories·Product code MVC·February 9, 2006

    Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic polyisoprene surgical glove, latex-free, used as an underglove when double-gloving; 1 pair of gloves per sterile pouch, 200 pairs per case; REF2D73PB85 - size 8-1/2; Cardinal Health, McGaw Park, IL 60085 USA, Made in Thailand. To be worn as an under glove by operating room personnel to protect a surgical wound from contamination in environments within the hospital and other healthcare facilities. The gloves are appropriate for using during invasive as well as non-invasive medical procedures requiring sterility. The Esteem Blue with Neu Thera surgeons glove is worn as an under glove, in conjunction with a primary surgical glove where the primary surgical glove comes into direct contact with the surgical wound.

    FDA Recall
    Terminated ·Cardinal Health·Product code KGO·April 24, 2009

    Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic polyisoprene surgical glove, latex-free, used as an underglove when double-gloving; 1 pair of gloves per sterile pouch, 200 pairs per case; REF2D73PB70 - size 7; Cardinal Health, McGaw Park, IL 60085 USA, Made in Thailand. To be worn as an under glove by operating room personnel to protect a surgical wound from contamination in environments within the hospital and other healthcare facilities. The gloves are appropriate for using during invasive as well as non-invasive medical procedures requiring sterility. The Esteem Blue with Neu Thera surgeons glove is worn as an under glove, in conjunction with a primary surgical glove where the primary surgical glove comes into direct contact with the surgical wound.

    FDA Recall
    Terminated ·Cardinal Health·Product code KGO·April 24, 2009

    Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic polyisoprene surgical glove, latex-free, used as an underglove when double-gloving; 1 pair of gloves per sterile pouch, 200 pairs per case; REF2D73PB75 - size 7-1/2; Cardinal Health, McGaw Park, IL 60085 USA, Made in Thailand. To be worn as an under glove by operating room personnel to protect a surgical wound from contamination in environments within the hospital and other healthcare facilities. The gloves are appropriate for using during invasive as well as non-invasive medical procedures requiring sterility. The Esteem Blue with Neu Thera surgeons glove is worn as an under glove, in conjunction with a primary surgical glove where the primary surgical glove comes into direct contact with the surgical wound.

    FDA Recall
    Terminated ·Cardinal Health·Product code KGO·April 24, 2009

    Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic polyisoprene surgical glove, latex-free, used as an underglove when double-gloving; 1 pair of gloves per sterile pouch, 200 pairs per case; REF2D73PB90 - size 9; Cardinal Health, McGaw Park, IL 60085 USA, Made in Thailand. To be worn as an under glove by operating room personnel to protect a surgical wound from contamination in environments within the hospital and other healthcare facilities. The gloves are appropriate for using during invasive as well as non-invasive medical procedures requiring sterility. The Esteem Blue with Neu Thera surgeons glove is worn as an under glove, in conjunction with a primary surgical glove where the primary surgical glove comes into direct contact with the surgical wound.

    FDA Recall
    Terminated ·Cardinal Health·Product code KGO·April 24, 2009